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ATAZANAVIR MYLAN, ATAZANAVIR ALPHAPHARM (Alphapharm Pty Ltd)
Product name
ATAZANAVIR MYLAN, ATAZANAVIR ALPHAPHARM
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
218 working days (255)
Active ingredients
Atazanavir sulfate
Registration type
New generic medicine
Indication
ATAZANAVIR MYLAN, ATAZANAVIR ALPHAPHARM (capsules) is indicated for the treatment of HIV 1 infection, in combination with other antiretroviral agents. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies.